Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

June 26, 2002


Validation of Procedures to Prevent Contamination and Cross-Contamination with TSE Agents of Human Tissue Inteded for Transplantation, TSEAC  ppt

Risk Assessments, Dr. Rolf Taff, PhD, FDA  ppt

Global Tally of Iatrogenic CJD  doc

Implications of Batch Processing for Manufacture of  Human Cells , Tissues & Cellular & Tissue-Based Products  ppt

Limiting Batch Size; Effects of Batch Size on Risk of Contamination with Infectious Agents, Dr. Thomas Lynch, JD, PhD, Regulatory and Quality  ppt

AATB Standards on Recovery & Processing Human Tissue  ppt

Safety Steps in Eye Banking, Ellen Heck, MT, MA, CEBT  ppt

Disinfection & Sterilization of TSE Contaminated Surgical Instruments Dr. Robert Rohwer, PhD, VA Medical Ctr, Baltimore, MD  pdf

Evaluation of Viral Clearance Studies, Dr. Mahmood Farshid, PhD, FDA  ppt

Validation of Bone Allograft Processing, Richard Russo, Osteotech, Inc.  ppt

Validation of the BioCleanse Tissue Sterilization Process, Dr. C. Randal Mills, PhD  ppt

Perspective on TSE Clearance Studies, Dr. Robert Rohwer, PhD, VA Medical Ctr, Baltimore, MD  pdf

Draft Guidance:  Preventive Measures to Reduce the Possible Risk of Transmission of CJD & cCJD by Human Cells, Tissues, and Cellular & Tissue-Based Products  ppt

Identification and Deferral of Tissue Donors for Possible BSE/vCJ-D Expososure: Estimating the Impact, Dr. Alan Williams, PhD, FDA  ppt